510(k) Report

Devices descending from K010938

721 later devices reach Syngo Multimodality Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+5K133490G-Scan BrioEsaote, S.p.A.201310—
+5K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+5K131385Easy-GraftDegradable Solutions AG20130—
+5K121916IntuitionTerarecon,Inc.201351
+5K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—
+5K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+5K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+5K111892Vitreaview Software 6.1Vital Images, Inc.201116—
+5K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+5K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+5K081018Syngo Dynamics Version 7.0Siemens Medical Solutions20088—
+6K260086CadAI-B DxBeamWorks, Inc.20260—
+6K261331I-Genius (100019400)Esaote, S.p.A.20260—
+6K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+6K2503303mensio WorkstationPie Medical Imaging BV202501
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K251766TumorSight VizSimBioSys, Inc.20250—
+6K242500LaralabLaralab GmbH20250—
+6K250416GBrain MRIGalileo Cds, Inc.20251—
+6K241984Hi-D Imaging 4TAVRHi-D Imaging AG20251—
+6K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+6K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+6K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+6K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+6K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+6K241440HealthCCSngNano-X AI, Ltd.20240—
+6K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+6K240582VEA Align; spineEOSEos Imaging20244—
+6K231324DASI Dimensions (V1.0)Dasi Simulations20240—
+6K231917VEA AlignEos Imaging20245—
+6K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+6K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+6K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+6K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+6K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K230112CAC SoftwareImbio, Inc.20230—
+6K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV20230—
+6K230223iCAC DeviceBunkerhill, Inc.20236—
+6K230023ART-PlanTherapanacea Sas20233—
+6K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+6K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc.20232—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+6K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K202056Kinepict Medical Imaging Tool 4.0Kinepict Health, Ltd.20210—
+6K203555AmCAD-UTAmcad Biomed Corporation20212—
+6K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+6K202212TruPlanCircle Cardiovascular Imaging, Inc.20213—
+6K203104IBM iConnect AccessMerge Healthcare Incorporated20212—
+6K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+6K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+6K200274CariCloudCaristo Diagnostics20200—
+6K192437Arterys MICAArterys, Inc.20202—
+6K192372ASCEND Image ViewerAscend Hit20200—
+6K192277CardIQ FlowGE Medical Systems SCS20200—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K191171EchoGo CoreUltromics, Ltd.20193—
+6K191544Synapse 3D Blood Flow AnalysisFujifilm Corporation20190—
+6K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K190874Materialise Mimics EnlightMaterialise NV20192—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K190178Monaco RTP SystemElekta, Inc.201945
+6K190232Synapse PACSFujifilm Corporation2019311
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+6K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+6K173475Merge PACSMerge Healthcare Incorporated201712
+6K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+6K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+6K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+6K163668SuitestensaEbit Srl20170—
+6K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+6K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+6K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+6K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+6K163285syngo Application SoftwareSiemens Medical Solution USA, Inc.201710—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K163253Arterys Cardio DLArterys, Inc.20174—
+6K160371NovaPACSNovarad Corporation20165—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—